Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants: a Pilot Study

NCT07508124 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: H-57427
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this smaller clinical trial is to evaluate the study design of this research to help prepare for a larger research study in the future. The future larger study would focus on whether steroid cream can reduce recurrent urinary tract infections in male infants, who are not circumcised. Male infants, who are enrolled in this study, would receive either the steroid cream or a placebo cream (a look alike cream without steroids). The cream would be applied twice a week for four weeks. Then there would be two follow up visits with the research team to measure whether the infant experienced any urinary tract infections and to measure parent perceptions of their experience participating in the study.

Conditions

Urinary Tract Infection

Keywords

urinary tract infection; uncircumcised male infants; betamethasone cream; steroid cream

Outcome Measures

Primary Outcomes (1)

• Feasibility of recruitment across different settings

  Defined as the consent rate of \>= 20% as stratified by setting (clinic/EC/inpatient)

  up to 2 weeks

Secondary Outcomes (13)

• Rate of recurrent urinary tract infection

  Between 14 days of completing antibiotics for the first urinary tract infection and through the last follow up visit, which occurs 6 months after randomization.

• Total number of recurrent urinary tract infections

  6 month follow up period

• Number of subsequent hospitalizations for recurrent urinary tract infections

  6 month follow up period

• Number of subsequent emergency department visits for recurrent urinary tract infection

  Within 6 month follow up period

• Rate of provider diagnosed recurrent urinary tract infection

  6 month follow up period

Study Arms (2)

Participants randomized to receive steroid cream

ACTIVE COMPARATOR

Drug: betamethasone valerate 0.1% cream

Participants randomized to receive placebo cream.

PLACEBO COMPARATOR

Drug: Placebo cream

Interventions

betamethasone valerate 0.1% cream DRUG

Steroid cream applied to the foreskin and glans twice a day for four weeks.

Participants randomized to receive steroid cream

Placebo cream DRUG

Placebo cream is applied to the foreskin and glans twice a day for four weeks.

Participants randomized to receive placebo cream.

Eligibility Criteria

• Age: 0 Months - 5 Months
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Uncircumcised male infants \< 6 months old
• Both physician and laboratory confirmed diagnosis of first UTI
• Fever (temperature ≥38.0 C) or hypothermia (temperature \<36.0 C) per ED/hospitalization or parental report

You may not qualify if:

• Legal guardian not available to provide informed consent
• Infant in Child Protective Services (CPS) custody
• Legal guardian would like Urology referral for circumcision
• Circumcision is medically indicated due to recurrent episodes of balanitis or ballooning of foreskin during urination
• Past diagnosis of penile abnormalities (diagnoses of epispadius, hypospadias or congenital penile curvature (chordee))
• Prior use of topical steroid therapy for phimosis
• History of hypersensitivity to topical steroids
• Legal guardian is not fluent in English OR Spanish
• Foreskin assessed to be fully retractable
• Open wounds present on penis or in groin region

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Seattle Children's Hospital: collaborator

Study Sites (3)

Texas Children's Hospital Main campus

Houston, Texas, 77030, United States

RECRUITING

Texas Children's Hospital West Campus

Katy, Texas, 77094, United States

NOT YET RECRUITING

Seattle Children's Hospital

Seattle, Washington, 98105, United States

NOT YET RECRUITING

Related Publications (7)

• Lee JW, Cho SJ, Park EA, Lee SJ. Topical hydrocortisone and physiotherapy for nonretractile physiologic phimosis in infants. Pediatr Nephrol. 2006 Aug;21(8):1127-30. doi: 10.1007/s00467-006-0104-8. Epub 2006 Jun 22.

  PMID: 16791612 BACKGROUND

• Chen CJ, Satyanarayan A, Schlomer BJ. The use of steroid cream for physiologic phimosis in male infants with a history of UTI and normal renal ultrasound is associated with decreased risk of recurrent UTI. J Pediatr Urol. 2019 Oct;15(5):472.e1-472.e6. doi: 10.1016/j.jpurol.2019.06.018. Epub 2019 Jun 25.

  PMID: 31345734 BACKGROUND

• Moreno G, Ramirez C, Corbalan J, Penaloza B, Morel Marambio M, Pantoja T. Topical corticosteroids for treating phimosis in boys. Cochrane Database Syst Rev. 2024 Jan 25;1(1):CD008973. doi: 10.1002/14651858.CD008973.pub3.

  PMID: 38269441 BACKGROUND

• Dave S, Afshar K, Braga LH, Anderson P. Canadian Urological Association guideline on the care of the normal foreskin and neonatal circumcision in Canadian infants (full version). Can Urol Assoc J. 2018 Feb;12(2):E76-E99. doi: 10.5489/cuaj.5033. Epub 2017 Dec 1. No abstract available.

  PMID: 29381458 BACKGROUND

• Conway PH, Cnaan A, Zaoutis T, Henry BV, Grundmeier RW, Keren R. Recurrent urinary tract infections in children: risk factors and association with prophylactic antimicrobials. JAMA. 2007 Jul 11;298(2):179-86. doi: 10.1001/jama.298.2.179.

  PMID: 17622599 BACKGROUND

• Khan A, Jhaveri R, Seed PC, Arshad M. Update on Associated Risk Factors, Diagnosis, and Management of Recurrent Urinary Tract Infections in Children. J Pediatric Infect Dis Soc. 2019 May 11;8(2):152-159. doi: 10.1093/jpids/piy065.

  PMID: 30053044 BACKGROUND

• Shaikh N, Morone NE, Bost JE, Farrell MH. Prevalence of urinary tract infection in childhood: a meta-analysis. Pediatr Infect Dis J. 2008 Apr;27(4):302-8. doi: 10.1097/INF.0b013e31815e4122.

  PMID: 18316994 BACKGROUND

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Betamethasone Valerate

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Betamethasone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Sowdhamini Wallace, DO, MS

CONTACT

18328245447; swallace@bcm.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: March 21, 2026
• First Posted: April 2, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The de-identified database and data dictionary will be available after publication of this study and up to five years after the publication date.
• Access Criteria: The database and data dictionary would be made available to researchers and clinicians after publication of this study. The data will be made available upon publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to Sowdhamini Wallace (swallace@bcm.edu).

Locations

US (3)